FDA 510(k)

HydroMARK Breast Biopsy Site Marker

K-Number: K212158 · 2022-04-21

Decision Date2022-04-21

Product CodeNEU

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

HydroMARK Breast Biopsy Site Marker is the device name listed in this FDA 510(k) record. The listed applicant is Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K212158. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HydroMARK Breast Biopsy Site Marker?

HydroMARK Breast Biopsy Site Marker is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K212158.

When did HydroMARK Breast Biopsy Site Marker receive FDA 510(k) clearance?

HydroMARK Breast Biopsy Site Marker received FDA 510(k) clearance on 2022-04-21, under 510(k) number K212158.

Who is the listed applicant for HydroMARK Breast Biopsy Site Marker?

The FDA 510(k) record lists Devicor Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HydroMARK Breast Biopsy Site Marker?

The FDA product code for HydroMARK Breast Biopsy Site Marker is NEU.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05547347Safety, Ultrasound Conspicuity, and Migration of Twinkling Markers in Patients With Locally Advanced Breast CancerSUSPENDED NCT06999798An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 TrialRECRUITING NCT07505797ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)RECRUITING

Other records listing Devicor Medical Products, Inc. as applicant

K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)K243095Mammotome AutoCore™ Single Insertion Core Biopsy System K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))K221961HydroMARK Plus Breast Biopsy Site Marker

View all 14 devices →

Related Devices (Code: NEU)

K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape)Devicor Medical Products, Inc.K253888MOLLI 2 SystemStryker Endoscopy K252892SCOUT MD Surgical Guidance SystemMerit Medical Systems, Inc.K251989VizMark Preloaded Tissue Marker Device (VM-0001)Breast-Med, Inc.K251748MammoSTAR Biopsy Site IdentifierCarbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ Breast Tissue MarkerBard Peripheral Vascular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.